Management of Distally Extension Maxillary Atrophied Ridge With Two Different Minimal Invasive Treatment Modalities

NCT ID: NCT05646498

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2023-06-22

Brief Summary

This study will compare clinical and radio graphic outcomes of two minimally invasive different treatment modalities for atrophied unilateral distal extension maxillary ridges these modalities include

1. Medially placed implant and Implant retained distal extension removable partial denture

2. Sinus lift and long implant to support fixed screw-retained prosthesis

Detailed Description

Patient selection:

For this study, 40 patients were selected from the clinic of Prosthodontics Department, Faculty of Dentistry, Mansoura University.

Inclusion criteria:

The patients will be selected according to the following:

• They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8 mm as verified by preoperative cone beam. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
• Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm covering.
• Patients are less satisfied with conventional removable partial denture.
• Absence of maxillary sinus diseases. Exclusion criteria

Patients were not eligible for this work if any of the following criteria were met:

• Acute or chronic sinus pathology
• History of a sinus augmentation in the past in the relevant sinus
• Poor dental hygiene. Smoker.
• Compromised general health (uncontrolled diabetes, bleeding disorder….). All patient were informed about all procedures that will be done and they sign the written consent form of ethical committee in faculty of dentistry Mansoura university.

Three treatment groups will be classified randomly, as follow:

• Group I: patients received one implant in premolar area medial to maxillary sinus and used to retain partial over-denture.
• Group II: patient underwent sinus lift and receive screw retained prosthesis on long implant All implants were inserted using computer guided and flap-less implant surgery and conventional loading protocol was used.

Evaluation methods Clinical and radio-graphic evaluation

1. Modified Plaque index. Assessment of plaque accumulation with a modified plaque index : Score 0: No detection of plaque, Score 1: Plaque only recognized by running a probe across the smooth marginal surface of the implant, Score 2 Plaque can be seen by a naked eye, Score 3 Abundance of soft matter.

2. Marginal index. Assessment of bleeding tendency with a modified bleeding index : Score 0 No bleeding when a periodontal probe is passed along the margin adjacent to the implant. Score 1 Isolated bleeding spot visible, Score 2 Blood forms a confluent red line on margin, Score 3 Heavy or profuse bleeding.

3. Attachment level. Distance from the junction implant/crown to the most apically probe able portion, in millimeters.

4. Pocket depth. Distance between the margin and the most apically probable portion, in millimeters Assessed by insertion of a standard periodontal probe with a point diameter of 0.5 mm using a probing force of 0.5 N.

5. Implant stability quotient. Using resonance frequency analysis b- Radio-graphic evaluation will be performed in terms of:

Vertical bone loss will be evaluated as follows:

The distance between implant plate form and first bone to implant contact will be evaluated after one year.

Conditions

Partial Edentulism Class 2 Due to Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

implant retained removable overdentures

Procedure: Long implant and partial overdentures insertion of long implants anterior to the maxillary sinus to retain partial overdentures

Device: Partial overdentures Distal extension metallic partial dentures retained by attachments to the implants

Group Type: ACTIVE_COMPARATOR

Closed sinus lift procedure

Intervention Type: PROCEDURE

The closed sinus lift is the elevation of the sinus membrane through the osteotomy

Crestal sinus lift

Intervention Type: DEVICE

The crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs.

implant supported fixed screw retained prosthesis

Procedure: Sinus lift and long implant performing sinus lift surgical procedure with simultaneous placement of limplants to support screw-retained prosthesis

Device: Metal ceramic prosthesis on long implants porcelain fused to metal fixed screw-retained prosthesis supported by implants

Group Type: ACTIVE_COMPARATOR

Closed sinus lift procedure

Intervention Type: PROCEDURE

The closed sinus lift is the elevation of the sinus membrane through the osteotomy

Crestal sinus lift

Intervention Type: DEVICE

The crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs.

Interventions

Closed sinus lift procedure

The closed sinus lift is the elevation of the sinus membrane through the osteotomy

Intervention Type: PROCEDURE

Crestal sinus lift

The crestal approach is the elevation of the sinus membrane by osteotomes, piezosurgery, or Densah burs.

Intervention Type: DEVICE

Other Intervention Names

Minimal invasive sinus lift; Minimal invasive sinus lift

Eligibility Criteria

Inclusion Criteria

• The patients will be selected according to the following:

• They have atrophied unilateral distal extension maxillary ridge and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
• Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
• Patients are less satisfied with conventional RPD.
• Absence of maxillary sinus diseases.

Exclusion Criteria

• • Acute or chronic sinus pathology

• History of a sinus augmentation in the past in the relevant sinus
• Poor dental hygiene. Smoker.
• Compromised general health (uncontrolled diabetes, bleeding disorder

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elgamal

Associate professor of removable prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Mansoura University Mansoura, Eldakahlia, Egypt, 35516

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

A01140420

Identifier Type: -

Identifier Source: org_study_id